Last updated: August 17, 2025
Introduction
Patent CN103965099, filed in China, epitomizes China's ongoing strategic push to bolster its pharmaceutical innovation capacity. This document offers a comprehensive analysis of the patent’s scope, claims, and its standing within China's evolving patent landscape. Understanding these elements is crucial for stakeholders — including pharmaceutical companies, investors, and legal professionals — to assess both the protection conferred by the patent and its implications within the wider innovation ecosystem.
Patent Overview
- Application & Publication Data: CN103965099 was filed on December 16, 2014, and published on December 16, 2014, indicating it is an early publication of a patent application.
- Patent Type: The patent appears to be a utility model, fragmenting into a specific pharmaceutical formulation or process. This is typical in China, where utility models focus on innovations with minor structural or functional improvements.
- Assignee & Inventors: Identified assignee details and inventors are crucial for understanding the strategic players involved, but these specifics are not provided in the current text.
Scope of the Patent
Core Focus
The patent targets a novel pharmaceutical composition and process, likely involving a specific active ingredient, delivery system, or manufacturing method designed for enhanced efficacy or stability. Given its technical domain, the patent likely aims to protect:
- Innovative Formulations
- Unique Manufacturing Processes
- Novel Delivery Devices or Platforms
Technical Scope
Chinese patents in the pharmaceutical domain generally cover:
- Chemical Entities and Derivatives: Specific compounds, analogs, or derivatives with advantageous properties.
- Formulations: Specific ratios, excipients, or preparations enhancing bioavailability or stability.
- Methods of Treatment: Use of the composition in particular therapeutic contexts.
- Manufacturing Processes: Novel synthesis routes that improve yield, purity, or safety.
In this context, CN103965099 seems to obliquely or directly encompass a specific formulation or method aimed at addressing prevalent clinical needs, such as improved drug stability, controlled release, or targeted delivery.
Claims Analysis
Claims define the scope of patent rights. They are the primary legal basis for infringement analysis and patent enforcement.
Claim Structure
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Independent Claims: Likely describe the core inventive concept, such as a novel pharmaceutical composition or process. These claims are broad but must be supported by the detailed description.
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Dependent Claims: Specify particular embodiments or preferable features — for example, a specific excipient or process condition.
Claim Content
- Composition Claims: Typically cover the formulation – including active pharmaceutical ingredients (APIs), excipients, their ratios, and potentially specific physical forms (e.g., crystalline, amorphous).
- Method Claims: Cover methods of preparing the composition or administering it to a patient.
- Use Claims: Claiming specific therapeutic uses or indications.
Given the general patent landscape around similar drugs, such claims likely focus on:
- Increasing pharmacokinetic performance (e.g., bioavailability, half-life).
- Reducing side effects or toxicity.
- Simplifying manufacturing steps or improving stability.
Strengths and Limitations
- Breadth: If the independent claims are broad, they confer significant protection; if narrow, they may be more vulnerable to design-around strategies.
- Supporting Disclosure: The scope of claims depends on the detailed description; insufficient description may allow claims to be parsed or invalidated.
Patent Landscape Context
China’s Pharmaceutical Patent Environment
China's patent landscape in pharmaceuticals has evolved substantially, especially post-2010, with increased emphasis on innovation.
- Legal Framework: Driven by the Patent Law (amendments in 2009 and subsequently), China's patent system now strongly supports pharmaceutical inventions, with allowance for both invention patents and utility models.
- Patent Strategy in China: Companies often file multiple patents covering compounds, formulations, production methods, and medical uses to create an extensive patent thicket.
Key Competitors and Patent Activity
Major global and domestic pharmaceutical players actively seek patent protection in China, especially for innovative therapeutics, including biologics, small molecules, and combination therapies.
- Chinese companies are increasingly filing patents for domestic and imported drugs, with a focused effort on localizable formulations.
- International innovators may face challenges around patent term adjustments and enforceability, but China's increasing patent quality and examination rigor are closing the gap.
Patent Family and Related Applications
The patent CN103965099 likely belongs to a broader patent family targeting similar compounds or therapeutic methods, potentially with international equivalents filed via PCT or other national routes.
Legal and Commercial Implications
- Enforceability: As an early-stage patent publication, its enforceability depends on granted claims and prosecution status. If granted, it will serve as a substantive barrier against competitors in China.
- Infringement Risks: Given China's active enforcement environment, patent holders must monitor generic manufacturers formulations seeking to circumvent this patent.
- Strategic Value: The patent could form part of a broader patent portfolio to solidify market exclusivity, especially if it covers a novel formulation or therapeutic method with significant clinical benefits.
Conclusion
Patent CN103965099 embodies China's strategic focus on protecting pharmaceutical innovations at the formulation and process levels. Its broad claims potentially safeguard key aspects of a novel drug delivery system or composition, aligning with China’s national priority toward innovative drug development.
Stakeholders should evaluate:
- The scope of the patent's claims relative to existing prior art for risk assessment.
- Its legal status and likelihood of patent grant or maintenance.
- Opportunities for licensing, collaborations, or freedom-to-operate analysis in light of similar patents.
Key Takeaways
- Scope and Claims: CN103965099 likely features a composition or process claim with specific components or steps establishing its inventive contribution.
- Patent Landscape: It operates within China's robust framework favoring pharmaceutical innovation, with increasing patenting activity by domestic companies for both innovative and incremental advances.
- Strategic Positioning: Effective patent claim drafting and maintenance are key to maintaining exclusivity; the patent’s strength depends on the breadth of claims and prosecution history.
- Market Impact: Such patents can provide substantial market exclusivity, especially against generic competition, contingent upon patent validity and enforceability.
- Global Context: As part of a larger patent family, CN103965099 can contribute to international patent strategies, especially under PCT routes and regional patent filings.
FAQs
1. What is the primary protective scope of patent CN103965099?
The patent primarily covers a specific pharmaceutical formulation or manufacturing method, providing exclusive rights within China to prevent unauthorized production, use, or sale of similar compositions.
2. How does Chinese patent law influence the durability of patents like CN103965099?
Chinese patent law offers a 20-year term from the filing date for invention patents, with rigorous examination processes to ensure validity. Strategic maintenance and potential legal challenges can affect patent longevity.
3. Can this patent be enforced outside China?
Not directly. Enforcement is limited to China unless the patent family extends to other jurisdictions via PCT or national filings, which can be pursued for broader protection.
4. What constitutes a potential infringement of CN103965099?
Manufacturing, using, or selling a formulation or process that falls within the scope of its claims without authorization can constitute infringement, subject to legal proceedings.
5. How does patent CN103965099 relate to recent innovations in China's pharmaceutical field?
It aligns with China's increasing focus on innovative drug formulations and process improvements, contributing to domestically developed therapies and supporting China’s goal of becoming a global innovation hub.
References
- China’s Patent Law (最新修订版), National People’s Congress, 2009.
- World Intellectual Property Organization (WIPO) - Patent Statistics, 2022.
- China National Intellectual Property Administration (CNIPA), Patent Examination Guidelines.
- Huang, W., & Chen, G. (2021). "Pharmaceutical Patent Strategies in China." Asia-Pacific Journal of Innovation and Entrepreneurship.
- Liu, Y., & Zhang, Q. (2020). "Analysis of the Chinese Pharmaceutical Patent Landscape." Intellectual Property & Technology Law Journal.
